Showing papers by "Alessandro Liberati published in 1986"
TL;DR: There was evidence that quality has improved over time and that the increasing tendency of involving a biostatistician in the research team was positively associated with the improvement of the internal validity but not with the external.
Abstract: The methodology of randomized control trials (RCTs) of the primary treatment of early breast cancer has been reviewed using a quantitative method. Sixty-three RCTs comparing various treatment modalities tested on over 34,000 patients and reported in 119 papers were evaluated according to a standardized scoring system. A percentage score was developed to assess the internal validity of a study (referring to the quality of its design and execution) and its external validity (referring to presentation of information required to determine its generalizability). An overall score was also calculated as the combination of the two. The mean overall score for the 63 RCTs was 50% (95% confidence interval [CI] = 46% to 54%) with small and nonstatistically significant differences between types of trial. The most common methodologic deficiencies encountered in these studies were related to the randomization process (only 27 of the 63 RCTs adopted a truly blinded procedure), the handling of withdrawals (only 26 RCTs in...
194 citations
TL;DR: Setting-dependent features more than individual provider attitudes seemed to account for at least part of the quality of information sharing behaviour as both hospital size and degree of hospital organization were - simultaneously - significant predictors of quality of communication, independently from patients' case-mix.
Abstract: In a study aimed at assessing whether and how patients with breast cancer are informed on their diagnosis and treatment a large group of physicians participating in a quality of care evaluation program were asked to report what they told patients about diagnosis and treatment. The completeness of such communication was then assessed using an explicit protocol designed to measure precision and lack of ambiguity of reported phrases. By this measure 39% patients received 'thorough' information on diagnosis and 11% 'detailed' information on surgery. These proportions become 48% and 14%, respectively, when only cases for whom answers were available are considered. Physicians, however, considered this communication 'thorough' for 69% of patients. Among patient-related characteristics, age, education and stage of disease were independent predictors of quality of information. Setting-dependent features more than individual provider attitudes seemed to account for at least part of the quality of information sharing behaviour as both hospital size (comparing centres larger than 500 beds and smaller ones) and degree of hospital organization (comparing centres adhering to the Italian Breast Cancer Task Force, FONCaM and those not) were - simultaneously - significant predictors of quality of communication, independently from patients' case-mix. Physicians' judgement - measured assuming the explicit protocol as standard - proved to be of acceptable sensitivity only when information was 'Thorough' by the protocol. However, its specificity and predictive values were consistently low in all three categories defined by the protocol, leading to high misclassification rates. The implications of these findings for studies aimed at assessing the quality of patients-providers communication are discussed.
52 citations
TL;DR: Using the data from published randomized control trials with a minimum two-year follow-up, pooled estimates of relapse-free survival rates and overall survival rates were calculated to illustrate its value as an explicit and systematic one for combining data from several randomized control Trials in assessing a therapeutic controversy.
Abstract: The use of adjuvant chemotherapy for treating patients with operable breast cancer remains a worldwide controversy. Using the data from published randomized control trials with a minimum two-year follow-up, pooled estimates of relapse-free survival rates and overall survival rates were calculated. Relapse-free survival rates were improved by 12.5% (95% confidence interval [CI] ±4.5%) at three years and by 8% (CI ±6%) at five years, with studies using multiple agents showing a greater effect. A significant advantage was also present in overall survival rates at three years, but only for studies involving multiple agents (4% ±3.5%). Results from combining data for other types of trials were inconclusive. The use of this method is presented to illustrate its value as an explicit and systematic one for combining data from several randomized control trials in assessing a therapeutic controversy. ( JAMA 1986;256:1148-1159)
46 citations
TL;DR: The quality of the diagnostic and therapeutic process of 1262 newly diagnosed breast cancer patients was evaluated in 63 Italian general hospitals over the period March 1983 - April 1984 and most of the patients discovered their own lesion, which was a nodule in 83 % of the cases.
Abstract: The quality of the diagnostic and therapeutic process of 1262 newly diagnosed breast cancer patients was evaluated in 63 Italian general hospitals over the period March 1983 - April 1984. Most of the patients (91 %) discovered their own lesion, which was a nodule in 83 % of the cases. Practice of breast self examination was reported by 418 (33 %) patients, only 28 % of whom did that on a regular monthly basis. A diagnostic delay > 3 months was present in 36 % of the patients. Among the preoperative work-up examinations, skeletal X-ray or bone scan was not performed in 20 % of patients, whereas other essential examinations were done in most. The Patey type of radical mastectomy was the most frequent surgical procedure; quadrantectomy was performed in only 26 % of eligible patients, more frequently in younger (34 %) than in older patients (21 %). Adjuvant chemotherapy was recommended for 11 % and 6 % of pre- and postmenopausal N— patients, and for 78 % and 47 % of pre- and postmenopausal N+ patients. Forty-three of the 63 participating hospitals reported they adhered to the guidelines defined by the Italian Breast Cancer Task Force (F.O.N.Ca.M.) but this was not associated with substantial evidence of better quality of care. Similarly, no associations emerged between several hospitals' organizational features and adherence to recommended treatment guidelines. The study is ongoing to assess the quality of postsurgical treatment and to measure its impact on patients' survival.
25 citations